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Heli-FX™ EndoAnchor™ System HG-18-90-42 (UDI 00763000006679)Recalls & reported problems

Medtronic, Inc. · TAA GUIDE DEVICE 42 EIFU · Class 2 · Implant

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Sep 13, 2017Terminated

    It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

    Z-3227-2017 · Root cause: Labeling Change Control · FDA record ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.